Pulmonary embolism, in which emboli from any of various regions of the vascular system pass into the lungs, accounts for thousands of deaths each year in the United States. Blood clots from the lower extremities are commonly carried to the heart through the inferior vena cava, and thence to the lungs.
Many patients with documented pulmonary embolism can be treated with anti-coagulants to prevent further formation of thrombi, but there are situations in which mechanical interruption of the inferior vena cava is the preferred method to prevent pulmonary embolism. To prevent blood clots from passing upwardly through the inferior vena cava, it has been suggested to place filters in the vena cava which filter out blood clots. An excellent but early description of vena cava filters is found in Palestrant, Aubrey, M, et al. Comparative In Vitro Evaluation of the Nitinol Inferior Vena Cava Filter, Radiology 145:351-355, November, 1982. A more recent treatment of the subject of vena cava filters is found in Interventional Radiology, 3rd Edition, Castaeda-Zuniga, Wilfredo R., ed., Williams and Wilkins, Baltimore, pp 854-896 (1997). Various filters are disclosed in Lebigot, U.S. Pat. No. 4,781,177, Simon, et al., U.S. Pat. No. 5,669,933 and Maderlinger, U.S. Pat. No. 5,720,764. Reference may be made also to Rasmussen, et al., U.S. Pat. No. 5,133,733, LeFebvre, U.S. Pat. No. 5,108,418, Goldberg, et al. U.S. Pat. No. 5,152,777 and El-Nounou, et al. U.S. Pat. No. 5,242,462.
In general, vena cava filters are introduced into the vasculature through a puncture or an incision in a major vessel such as the internal jugular vein and the filter, elastically restrained in a delivery catheter, is passed from the jugular vein through the right atrium of the heart and into the inferior vena cava whereupon the filter is mechanically expelled from the catheter and expands into contact with the lumen. Various hook-like projections have been suggested for use in holding the filter in place once the delivery catheter has been withdrawn. When a filter using hooks, barbs and the like to retain it in place permanently is thus to be removed, surgical intervention is usually required.
Temporary introduction of a vena cava filter may be desired to provide rapid protection against pulmonary embolism, but as the condition producing blood clots is successfully treated, it may be desired to remove the filter from the vena cava. Vena cava filters commonly include a hub or central portion from which radiate outwardly a plurality of wires, sometimes in a woven configuration, the wires serving to filter clots from blood flowing through the vein. It is not uncommon for the central portion of the filter element, which is to be near the center of the lumen, to have the greatest efficiency, that is, to have wires that are closest together to thus produce smaller openings through which blood flows. The screen openings often become larger toward the walls of the vein. For good results, it is desired that the center of the filter remain near the center of the vessel, but often this is not easily controlled and the center of the filter may tilt to one side or the other of the lumen, thus exposing the less efficient areas of the filter to blood flow at the center of the lumen and reducing filtering efficiency.
Also, it is sometimes difficult to visualize with accuracy the effectiveness of a vena cava filter in filtering out blood clots. Commonly, an imaging or contrast medium such as Hipaque(copyright) (a product of Winthrop Pharmaceutical) or Conray(copyright) (a product of Mallinckrodt) may be injected upstream from the filter (that is, inferior to the filter in the vena cava) in the course of obtaining a vena cavogram, but the contrast liquid often becomes diluted in the blood stream as it reaches the filter, preventing precise visualization of blood clots in the filter. Moreover, to obtain a good vena cavogram, a large volume, e.g., 30 cc, of a contrast medium must be rapidly injected, and this procedure often is done with the aid of a diagnostic catheter.
Although, as thus described, a variety of vena cava filters have been suggested for use, the need remains for a filter that can be temporarily installed in the vena cava for later removal, and for a filter enabling blood clots captured by it to be readily visualized by the introduction of a contrast medium. It would be particularly desirable to provide a filter assembly capable of deploying an easily removable filter element, but that may also deploy an anchoring element proximal to (that is, downstream from) the filter element, as warranted by a patient""s condition. It would also be desirable to provide a filter, the center or apex of which is positioned and maintained at or near the center of the lumen, so as to improve clot filtering efficiency. Moreover, it would be desirable to provide a filter assembly enabling a contrast medium or other fluid to be injected upstream from the filter elements.
We have developed a filter assembly capable of deploying a filter element or both a filter element and an anchoring element in vessels of the body such as the vena cava and other vessels of the body, particularly in the vasculature and especially in the larger vessels. In a preferred embodiment, our filter assembly has a configuration that enables apices of these elements to remain substantially in the center of the lumen to improve filter efficiency, whether the filter assembly is deployed in its temporary or permanent configuration. For ease of explanation, the filter assembly of our invention will be described in connection with its use in the vena cava, but it will be understood that the filter assembly may be employed in various other vessels of the body.
Our filter desirably is so constructed as to enable it to deploy a distal filter element in a temporary configuration or, in a permanent configuration, to add an anchoring element. When only the filter element is deployed, the filter assembly remains attached to a tether that enables the filter to be removed from the body or repositioned in the vessel. Upon deployment of the anchoring element, the tether is detached and withdrawn, leaving the filter assembly comprising both the filter and anchoring elements in place in the vessel.
Thus, in one embodiment, the invention provides a catheter-deliverable filter assembly for deployment in a vessel of the body in alternatively a temporary configuration in which only a filter element is deployed that can be removed from or repositioned in the vessel or a permanent configuration in which an additional anchoring element is deployed which grips the walls of the vessel. The filter assembly comprises an elongated support having proximal and distal ends. Separate filter and anchoring elements are spaced axially along the support, and each element comprises a core carried by the support and a plurality of flexible, resilient wires having proximal portions attached to the core and distal portions extending outwardly distally of the core and configured to resiliently contact walls of a vessel. The wires of each element converge proximally toward their respective cores to define apices of the elements, the filter element being spaced distally of said anchoring element. The anchoring element alone includes gripping elements adapted to grip the walls of a vessel to anchor the filter assembly in the vessel.
The filter assembly in one embodiment includes a hollow flexible tether releasably attached to the distal end of the elongated support and having a tubular, distal end portion within which are resiliently confined the wires forming said anchoring element when only the distal filter element is deployed. The filter assembly desirably also includes a delivery catheter having an inner bore within which the core and wires of the filter element are received in an elastically restrained orientation to enable delivery of the filter assembly to the vessel, whereupon withdrawal of the delivery catheter enables the wires of the filter element but not the anchoring element to be deployed in the vessel.
When the filter assembly has been properly placed within the vena cava, the delivery catheter is removed to deploy the wires of the filter element, the wires of the anchoring element remaining confined within the hollow end portion of the tether. As so deployed in its temporary or tethered configuration, the filter can be withdrawn from the body easily and without significant surgical intervention.
For deployment of the filter assembly in a permanent configuration, the hollow end portion of the tether is withdrawn proximally from the anchoring element to free its wires and enable them to expand divergently from the anchoring element core to deploy within the vessel, the gripping elements carried by the anchoring element wires engaging the surface of the lumen to anchor the filter assembly in the vena cava with the apex of each element being supported by its wires substantially in the center of the vessel.
Accordingly, the invention in another embodiment comprises a method for deploying a filter in the lumen of a patient""s vessel. The method comprises the following steps:
a. A filter assembly is provided which includes an elongated support having proximal and distal ends, and axially spaced filter and anchoring elements, each element comprising a core mounted coaxially to the support and having a plurality of flexible, resilient wires extending distally from its core. The anchoring element is spaced proximally from the filter element and has wires containing gripping elements for gripping the walls of a vessel. The assembly includes a delivery catheter having an inner bore within which said filter element core and wires are slidably received in an elastically restrained orientation and having a distally open end. A flexible tubular tether is carried slidably within the delivery catheter and has a hollow distal end portion releasably locked to the proximal end of the elongated support, the hollow distal end portion of the tether extending distally over and elastically restraining the wires of the anchoring element.
b. The delivery catheter is inserted into the vessel until its distal end is positioned adjacent the desired location for the filter element. The tubular tether, carrying at its distal end the elongated support together with the filter and anchoring elements, is slidable within the delivery catheter to deliver the elastically restrained filter element wires to the distal end of the catheter.
c. The delivery catheter is proximally removed to free the wires of the filter element to enable them to elastically contact the lumen of the vessel with the proximal portions of said wires converging proximally to form the apex of the filter element and with portions of the distal wire end portions of the filter element laying in line contact against and along the lumen of the vessel for a distance sufficient to substantially center said filter element apex in the lumen. If it is desired to reposition or remove the filter element, the wires of the filter element may be drawn back within the delivery catheter.
To deploy the anchoring element of the filter assembly, the method includes the step of unlocking and proximally withdrawing the hollow tether from the elongated support to thereby free the wires of the anchoring element from the hollow tether and enable them to elastically diverge into engagement with and grip the walls of the vessel to anchor the filter assembly within the vessel, the wires of the anchoring element converging proximally to form a second apex supported substantially in the center of the vessel.
Preferably, the wires of each of the filter and anchoring elements are so disposed with respect to each other as to be out of contact with each other distally of their respective apices when the filter assembly is deployed in the lumen of a vessel. At least a portion of the length of each wire, desirably a distal end portion, may be spiraled axially in the same direction (that is, either clockwise or counter-clockwise) about the axis of the elongated support to enable the wires to be readily elastically collapsed for receipt within the delivery catheter or the hollow distal end of the tether, as the case may be, the spiral orientation of the wires enabling the wires to diverge upon release from the delivery catheter or tether into contact with the walls of the vena cava without tangling of the wires with one another.
In a preferred embodiment, the elongated support is tubular and serves as an infusion tube that extends distally from the apex of the filter element to enable a contrast medium or drug or other liquid to be injected into the vena cava just distally of (that is, upstream from) the apex of the filter element so that the fluid immediately encounters any captured blood clots and enables them to be visualized or dissolved or otherwise treated, as the case may require. In this embodiment, the flexible tether is tubular and is attached at its distal end to the tubular support in fluid communication therewith to supply contrast medium or drug to the infusion tube, the proximal end of the tether being accessible for this purpose outside the body. The elongated support also may be made as a solid, preferably at least slightly flexible rod, and the flexible tether in this embodiment may deliver a contrast medium or other liquid around, rather than through, the elongated support with the liquid in any event exiting into the vessel at or upstream from the apex of the filter element.
The line contact between the distal portions of the filter element wires and the walls of the lumen serve not only to center the filter apex in the lumen, but to also substantially center the distal end of the infusion tube in the lumen, the infusion tube thus extending substantially parallel to the vessel. Such line contact also inhibits penetration of the walls of the vena cava by ends of the wire.
When only the filter element is deployed, the tether, which is sufficiently stiff as to resist collapse in the vena cava, also serves to support, center, and maintain that filter element and infusion tube in its tethered configuration within the lumen of the vena cava. The tether has a distal end portion that releasably and rigidly locks to the tubular support such that when the delivery catheter is removed, the tether will remain in place for the purpose of maintaining and centering the filter element within the vena cava and for supplying a liquid such as a contrast medium just upstream from the filter element.
The unique characteristics of the filter deployment assembly of the invention provide physicians, particularly interventional radiologists, with various options for deployment of the filter assembly in either its temporary or permanent configuration. As described in greater detail below, the tether together with the filter assembly is slidably received within the delivery catheter with the filter element wires remaining elastically confined within the delivery catheter as the filter assembly is moved within the delivery catheter. When the catheter has been appropriately positioned within the vena cava, using routine central venous access techniques, the filter assembly is slidably moved to the distal end of the delivery catheter, if it is not already there, and the delivery catheter is removed proximally, freeing the filter element wires which then elastically expand into contact with the walls of the vena cava. The resulting tethered or temporary configuration of the filter assembly enables a fluid such as a contrast medium to be injected from the hollow tether and through or around the elongated support, and also permits the filter element to be repositioned in the vessel or to be withdrawn proximally from the body, with the aid, if needed, of a catheter such as the delivery catheter that is passed over the tether to confine the previously freed wire portions within the catheter.
If desired, the entire filter assembly may be deployed in the lumen by passing it through a properly positioned delivery catheter, using a dilator or other push-rod within the catheter.
To permanently deploy the filter assembly, a flexible release rod may be inserted into the tether and passed along into contact with the lock that releasably locks the tether to the elongated support. Distal movement of the rod with respect to the tether at this point unlocks the tether from the support. Withdrawal of the thus released tether while holding the elongated support axially stationary with the release rod frees the wires of the anchoring element from the confinement of the distal end portion of the tether. Unconfined, the anchoring element wires elastically expand radially, the wires in this configuration converging at the filter core to form the apex of the permanently deployed filter. Gripping elements, such as proximally facing hooks, prongs or the like, are carried by the anchoring element wires. As the latter wires are elastically pressed against the vessel walls, the gripping elements grip the walls to anchor the filter assembly in place. The filter assembly with both elements deployed is thus left behind as a permanently deployed filter assembly as the tether is removed from the body. By xe2x80x9ccentrally disposedxe2x80x9d or xe2x80x9capproximately centeredxe2x80x9d or the like in connection with the position of the apex of each element within the lumen, we mean that the apex is positioned within about the central one-half, preferably the central one-third, of the diameter of the lumen.
The vena cava and other large vessels of the venous system are thin walled and are easily perforated. The wires of the filter and anchoring elements, and preferably at least those of the filter element, may terminate in enlarged ends which may be rounded or generally spheroidal, the enlarged ends inhibiting penetration of the walls of the vena cava by the distal ends of the wires.
Upon deployment of only the filter element in the vena cava, with the tubular tether attached, the proximal end portion of the tether that protrudes from the entry site of the internal jugular vein or other vessel where catheter entry was gained can be buried beneath the skin for a number of centimeters using known tunneling techniques, the wound over the entry site being closed to prevent infection. The proximal end of the tether protrudes from the skin at a location removed from the entry site and may terminate in an access element such as a controlled access hub of known design. The access element, such as a luer lock hub, provides immediate access to the tether for the purpose of delivering a contrast medium or other fluid just upstream from the filter element. If the tether is to be removed, either in the course of withdrawing the filter assembly from the vena cava or in the course of deploying the filter assembly in its permanent configuration, as discussed above, the access element is detached, the entry site is surgically opened, the buried proximal length of the tether is easily withdrawn from the subcutaneous tunnel, and the tether is then withdrawn from the vasculature.
In its tethered configuration, the filter element with its elongated support serving as an infusion tube provides excellent access to the interior of the vena cava at a location distal to or at the apex of the filter element and preferably upstream therefrom. When a fluid is injected for the purpose of visualizing a captured clot or for management of clots, it is anticipated that less fluid will be required because the fluid is concentrated at the clot location rather than being diffused in the blood flow far upstream from the filter. Moreover, use of the infusion tube for this purpose avoids the necessity of performing a costly and time consuming secondary site access procedure to utilize a separate catheter. The infusion tube may be used for the infusion of anticoagulants in clot management, for infusion of chemotherapy drugs, systemic antibiotics and for parenteral feeding, as well as enabling the collection of blood samples.
It will be understood that it is important that the wires forming the filter and anchoring elements, being bent as they are, be prevented from rotating about their respective axes. The wires commonly are quite fine, in the order of 0.005 to about 0.025 inches (about 0.13 mm to about 0.6 mm) in diameter, and it is difficult to mount the wires in bores formed in the cores in a manner preventing rotation of the wires in the bores. We have found that the wires can be easily attached to the cores in a manner that prevents their rotation, by providing a series of circumferentially spaced, axially extending bores through the cores, doubling a length of wire back upon itself to form two legs, and threading the legs distally through different, preferably adjacent, circumferentially spaced bores in the core. Each of the wire lengths, then, forms two distally-extending wires.